Transfer the following manufacturing steps to a new building: purification of antibodies and proteins and manufacturing of antibodies and proteins labelled with biotin or ruthenium complex. In addition, lyophilization of bulk raw materials necessary for production of elecsys assays will be moved to another new building.
| Device | ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK |
| Classification Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Generic Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | ROCHE DIAGNOSTICS CORP. |
| Date Received | 2016-02-18 |
| Decision Date | 2016-03-16 |
| PMA | P000027 |
| Supplement | S022 |
| Product Code | LTJ |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000027 | | Original Filing |
| S036 |
2021-10-18 |
30-day Notice |
| S035 |
2019-11-27 |
Normal 180 Day Track |
| S034 |
2019-01-29 |
Real-time Process |
| S033 |
2018-10-26 |
Normal 180 Day Track No User Fee |
| S032 |
2018-10-01 |
30-day Notice |
| S031 |
2018-04-17 |
Real-time Process |
| S030 |
2018-03-01 |
Real-time Process |
| S029 | | |
| S028 |
2017-10-11 |
Real-time Process |
| S027 |
2017-08-28 |
Normal 180 Day Track |
| S026 |
2017-08-03 |
30-day Notice |
| S025 |
2017-05-24 |
30-day Notice |
| S024 |
2016-10-26 |
30-day Notice |
| S023 |
2016-09-07 |
Normal 180 Day Track No User Fee |
| S022 |
2016-02-18 |
30-day Notice |
| S021 |
2015-10-07 |
30-day Notice |
| S020 |
2014-11-25 |
30-day Notice |
| S019 |
2014-04-04 |
Real-time Process |
| S018 |
2013-04-09 |
Real-time Process |
| S017 |
2012-12-19 |
135 Review Track For 30-day Notice |
| S016 | | |
| S015 |
2012-02-29 |
30-day Notice |
| S014 |
2012-01-31 |
135 Review Track For 30-day Notice |
| S013 |
2011-11-22 |
30-day Notice |
| S012 |
2011-08-01 |
Normal 180 Day Track |
| S011 |
2011-05-03 |
Normal 180 Day Track No User Fee |
| S010 |
2011-04-25 |
30-day Notice |
| S009 |
2011-04-11 |
135 Review Track For 30-day Notice |
| S008 |
2010-05-27 |
30-day Notice |
| S007 |
2008-09-02 |
30-day Notice |
| S006 |
2008-03-28 |
Normal 180 Day Track |
| S005 |
2007-07-23 |
Normal 180 Day Track |
| S004 |
2006-12-22 |
30-day Notice |
| S003 | | |
| S002 |
2002-10-11 |
Normal 180 Day Track |
| S001 |
2001-11-07 |
Normal 180 Day Track |
NIH GUDID Devices